FDA approves first new drug for liver cancer in decade
pharmafile | April 28, 2017 | News story | Medical Communications, Sales and Marketing | Bayer, Stivarga, hepatocellular carcinoma, liver cancer
The FDA has announced that it has approved the first new treatment for hepatocellular carcinoma (HCC), a type of liver cancer, since the approval of sorafenib in 2007. Stivarga is produced by Bayer and gained approval after receiving Priority Review designation; in clinical trials, the drug was found to boost overall median survival by 3.1 months over standard treatment.
The trials took place in 573 patients with HCC whose tumours had progressed after receiving sorafenib. The results showed that patients taking Stivarga demonstrated an improvement of median overall survival to 10.6 months, compared to 7.8 months in patients taking placebo. The median progression-free survival displayed a modest boost of 3.1 months, of those taking Stivarga, against 1.5 months with placebo treatment.
According to Bayer, Stivarga is an oral inhibitor of multiple kinases involved in normal cellular functional and in pathological processes such as oncogenesis, tumour angiogenesis, metastasis and tumour immunity. The drug is already approved to treat colorectal cancer and gastrointestinal stromal tumours.
The main cause for concern that has been raised after approval is that, despite showing modest improvement over standard treatment, there is a heavy list of potential side-effects. The most common of which are gastrointestinal and abdominal pain, fatigue and diarrhoea.
“Limited treatment options are available for patients with liver cancer,” said Richard Pazdur, Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “This is the first time patients with HCC have had an FDA-approved treatment that can be used if their cancer has stopped responding to initial treatment with sorafenib.”
Liver cancer will be diagnosed in approximately 40,710 people in 2017, with HCC being the most common type of liver cancer; this means that many people will become eligible for treatment with the drug. The treatment will be administered in cases where the patient has been previously treated with sorafenib.
HCC is particularly deadly, with statistics showing that between the years 2007-2013 only 17.6% of people survived five years after diagnosis. The extension of life, even if by only a marginal amount, could make a significant difference to patients’ lives and make the drug worth the potential side-effects.
Ben Hargreaves
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